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WARNING LETTER
•www.beclassifieds.com

www.beclassifieds.com – FDA Warning Letter

Record Details

The FDA's Center for Tobacco Products reviewed http://www.beclassifieds.com and found cigarette products offered for sale to U.S. customers in violation of the FD&C Act. The products, including Djarum Black, Djarum Super, and Gudang Garam varieties, are deemed adulterated under section 902(5) or misbranded under section 903(a)(1) or 903(a)(7)(A) because they purport to contain characterizing flavors (e.g., clove, cappuccino, fruit), which is prohibited for cigarettes under section 907(a)(1)(A). If these products do not contain such flavors, their labeling is considered false or misleading.

Additionally, several cigarette products (Gudang Garam Professional, Gudang Garam Surya 16, Djarum Black 16, Djarum Black Cappuccino 16, Gudang Garam Merah 12, Gudang Garam International, and Djarum Super 12) are misbranded under section 903(a)(7)(B) because they are sold in packages containing fewer than 20 cigarettes (12 or 16 per pack), violating 21 C.F.R. § 1140.16(b).

The FDA requires immediate corrective action, including discontinuing the violative labeling, advertising, sale,

Company
www.beclassifieds.com
Product type
Tobacco
Office
Center for Tobacco Products
Person
  • Ann Simoneau (Director)
View Company Profile

ID · e3a9c661-6762-468d-aeb2-29a61f92ea2f

Violation Codes8
21 U.S.C. 387g(a)(1)(A)21 CFR 1140.16(b)21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387b(5)21 U.S.C. 387c(a)(1)21 U.S.C. 387c(a)(7)(A)21 U.S.C. 387c(a)(7)(B)

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